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Os2®-V
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T10 SS908Ref T10 SS260Ref T10 SS900
by In2Bones SAS
Identity
- Trade Name
- OS2®-V EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- OS2-V VARISATION STAPLE KIT EUDAMEDOS2-V VARISATION STAPLE KIT, INTERAXIS 8 mm 90° FDA UDIOS2-V VARISATION STAPLE KIT, INTERAXIS 10 mm 90° FDA UDIOS2-V VARISATION STAPLE KIT, INTERAXIS 10 mm 26° FDA UDI
- Model / Reference
- T10 SS908 EUDAMEDFDA UDIT10 SS260 EUDAMEDFDA UDIT10 SS900 EUDAMEDFDA UDI
- Description
- OS2-V VARISATION STAPLE KIT, INTERAXIS 8 mm 90° FDA UDIOS2-V VARISATION STAPLE KIT, INTERAXIS 10 mm 90° FDA UDIOS2-V VARISATION STAPLE KIT, INTERAXIS 10 mm 26° FDA UDI
Identifiers
- Catalog Number
- T10 SS908 FDA UDIT10 SS900 FDA UDIT10 SS260 FDA UDI
- Primary DI / UDI-DI
- 03760225710838 EUDAMEDFDA UDI03760225710807 EUDAMEDFDA UDI03760225710821 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225710838 EUDAMEDB-03760225710807 EUDAMEDB-03760225710821 EUDAMED
- 510(k) Number
- K143323 FDA UDI
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P09120101 OSTEOSYNTHESIS STAPLES EUDAMED
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 90 degree FDA UDIAngle — 26 degree FDA UDI
Os2®-V by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225710838 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (9)
- EUDAMED ffe30ab4-d0fc-476a-84e3-3c841947b38e 61 fields · synced Jul 26, 2026
- EUDAMED 487f1a4b-2588-44c2-be85-17c356b84806 61 fields · synced May 18, 2026
- EUDAMED 203d4a03-5c4f-47ec-8c51-8df1e6276fda 61 fields · synced May 18, 2026
- FDA UDI 3915dfcd-5bec-4b0a-9b6e-3706d8396450 37 fields · synced May 30, 2026
- FDA UDI 7b48d629-6670-4b07-ad43-4fea237112f5 37 fields · synced May 30, 2026
- FDA UDI 7a359e97-882b-43f9-8c84-9f0ff6d44655 37 fields · synced May 30, 2026
- EUDAMED c2feb1ba-eb70-46dd-a3e1-087800b8f76e 61 fields · synced Jul 12, 2026
- EUDAMED 6e6bb7b5-594f-4072-856b-914dfbbcd84b 61 fields · synced Jul 13, 2026
- EUDAMED 5b83ef22-ce8b-4913-9772-c57e2b961ef6 61 fields · synced Jul 26, 2026